Roche Diagnostics Operations, Inc.
9 FDA actions
cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464
Roche Diagnostics Operations, Inc.
The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and el
Roche Diagnostics Operations, Inc.
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for
Roche Diagnostics Operations, Inc.
Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determina
Roche Diagnostics Operations, Inc.
Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 31
Roche Diagnostics Operations, Inc.
cobas infinity central lab, Material Number 07154003001
Roche Diagnostics Operations, Inc.
cobas e801 Immunoassay Analyzer
Roche Diagnostics Operations, Inc.
Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of t
Roche Diagnostics Operations, Inc.
cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Roche Diagnostics Operations, Inc.